First Wave BioPharma Completes Merger Deal With ImmunogenX Adding Phase 3-Ready Candidate For Celiac Disease
First Wave BioPharma Completes Merger Deal With ImmunogenX Adding Phase 3-Ready Candidate For Celiac Disease
First Wave BioPharma Inc (NASDAQ:FWBI) has acquired ImmunogenX in an all-stock transaction with the combined company focused on advancing a gastrointestinal (GI) pipeline.
First Wave BioPharma Inc（纳斯达克股票代码：FWBI）已通过全股交易收购了ImmunoGenX，合并后的公司专注于推进胃肠道（GI）管道。
First Wave BioPharma signed a non-binding term sheet in December to acquire ImmunogenX.
First Wave BioPharma在12月签署了一份不具约束力的条款表，以收购ImmunoGenx。
James Sapirstein will continue to serve as Chairman and CEO of First Wave BioPharma, with Dr. Jack Syage, previously the CEO and Co-Founder of ImmunogenX, assuming the role of President and Chief Operating Officer of First Wave BioPharma.
詹姆斯·萨皮尔斯坦将继续担任第一浪生物制药的董事长兼首席执行官，前ImmunoGenx首席执行官兼联合创始人杰克·赛格博士将担任第一浪生物制药的总裁兼首席运营官。
First Wave BioPharma intends to license the commercial rights to latiglutenase in the U.S. and Canada to a global pharmaceutical company.
First Wave BioPharma打算将美国和加拿大的latiglutenase的商业权利许可给一家全球制药公司。
It will also seek to secure financing commitments from a syndicate of institutional healthcare investors in the second half of 2024 to fund the ongoing development of latiglutenase.
它还将寻求在2024年下半年获得机构医疗保健投资者集团的融资承诺，为latiglutenase的持续开发提供资金。
"We expect to finalize these agreements prior to initiating preparatory work for the Phase 3 latiglutenase trials," Sapirstein said.
萨皮尔斯坦说：“我们希望在启动3期拉提谷蛋白酶试验的准备工作之前敲定这些协议。”
Latiglutenase, an oral biotherapeutic composed of two gluten-specific recombinant proteases, has demonstrated effectiveness in reducing intestinal damage and alleviating symptoms of celiac disease in two Phase 2 trials involving approximately 200 patients.
Latiglutenase是一种由两种麸质特异性重组蛋白酶组成的口服生物疗法，在涉及约200名患者的两项2期试验中，已证明可有效减少肠道损伤和缓解乳糜泻症状。
The Phase 3 clinical plan for latiglutenase has been reviewed by the GI Division of the FDA, and the trials are anticipated to begin in early 2025 compared to 2H of 2024 expected earlier.
Latiglutenase的3期临床计划已经过美国食品药品管理局胃肠道部的审查，这些试验预计将于2025年初开始，而早些时候预计的2024年下半年开始试验。
"Completion of the acquisition of ImmunogenX and the addition of latiglutenase to our clinical pipeline is a transformative event for First Wave BioPharma as it provides our company with a Phase 3-ready asset in a multibillion-dollar GI market – celiac disease – for which no approved pharmacologic treatment currently exists," Sapirstein added.
萨皮尔斯坦补充说：“完成对ImmunoGenX的收购以及将latiglutenase添加到我们的临床产品线中是First Wave BioPharma的变革性事件，因为它为我们公司提供了价值数十亿美元的胃肠道市场——乳糜泻——的三期就绪资产，该市场目前尚无经批准的药物治疗方法。”
Upon closing the acquisition, the company issued 365,162 shares of its common stock to the shareholders of ImmunogenX, equal to 19.02% of its currently issued and outstanding common stock and 11,777.418 shares of its newly issued Series G Convertible Preferred Stock.
收购完成后，该公司向ImmunogenX的股东发行了365,162股普通股，相当于其当前已发行和流通普通股的19.02％，以及其新发行的G系列可转换优先股的11,777.418股。
In December, First Wave BioPharma entered a non-binding term sheet to sell its Niclosamide program for treating inflammatory bowel diseases.
12月，First Wave BioPharma发布了一份不具约束力的条款表，出售其治疗炎症性肠病的尼氯沙胺计划。
Price Action: FWBI shares closed at $6.53 on Wednesday.
价格走势：FWBI股价周三收于6.53美元。